MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AISYS; ANESTHESIA GAS MACHINE

Device Problem Tidal Volume Fluctuations (1634)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information could not be obtained after multiple attempts.Attempts were made as follows: 9/28/2016 - voicemail, 9/29/2016 - voicemail, 10/6/2016 - voicemail.A ge healthcare biomed performed a checkout of the equipment and confirmed the reported complaint.Inspection of the equipment noted that the expiratory flow sensor diaphragm was stuck to the top of the flow sensor housing.The flow sensors were replaced.

Event Description

The hospital reported that, during a case, the machine was alarming and tidal volume readings were not available.There was no reported patient injury.

• Brand Name: AISYS
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI 53718
• Manufacturer Contact: joseph seliga ; 3000 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 6033851
• MDR Text Key: 57626870
• Report Number: 2112667-2016-02031
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1